The Swedish ministers have defined the health policy program that Sweden will carry during its Presidency of the Council of the EU. On the agenda: measures to combat loneliness and the establishment of a European health data space, among others.
“These six months will be very busy, and the Swedish presidency is prepared for what is on the agenda and to deal with the unexpected”Jakob Forssmed, Sweden’s Minister for Social Affairs and Public Health, told MEPs on the European Parliament’s Health Committee (ENVI) on Monday (23 January).
Stockholm began its presidency on January 1 against a difficult backdrop: overstretched healthcare systems, drug shortages, the fallout from Russian aggression in Ukraine, the Covid-19 pandemic as well as a busy legislative agenda including the strategy for Europe and the European Health Data Area (EHDS).
Sweden stressed that a coordinated approach will be essential. “It is vital to maintain close dialogue and cooperation at EU level, with the European Parliament being a natural and, I would say, crucial partner in this respect”underlined Mr. Forssmed.
The Minister added that this also applies to international negotiations regarding the international treaty on the prevention of pandemics and additional amendments to the international health regulations.
European health data area
Among the main pieces of legislation is the European Health Data Area (EHDS), one of the central elements of the European Health Union, which should be finalized by June 2024. The aim is that the EHDS to be operational in 2025.
Many stakeholders have already expressed concerns about the timingwarning that the EHDS might not be ready on the date originally planned.
“It is very important that the work progresses”, said Mr. Forssmed. He further described data sharing as a central issue for Europe which, if resolved, would enable health data to be shared across the EU for individuals, researchers and policy makers.
In this regard, he stressed the importance of respecting the existing narrow border “between what we want to achieve and data protection, so that everyone feels secure in the way their data is managed”.
This involves aligning the EHDS with other pieces of legislation, such as the Data Regulation (DataAct), the revised directive on the security of network and information systems (NIS 2), the regulation on artificial intelligence (AI Act) and the proposed national provisions on health data.
Another piece of legislation on the Swedish Presidency’s list is the Commission’s proposed new regulations on substances of human origin (SoHO), which would replace the current criteria, which were put in place more than 20 years ago.
The objective of the Swedish Presidency is not only to update it, but also to make it “stand the test of time”.
“We will take forward the proposed regulation on quality and safety standards for substances of human origin intended for human application”said Acko Ankarberg Johansson, Swedish Minister of Health.
EMA fee system
The European Commission is currently reviewing the fee system of the European Medicines Agency (EMA), in order to make it more flexible to adapt to future developments and more sustainable in the long term.
Ms Johansson said the Swedish presidency would push forward the EMA fee regulation.
“The system should be made as flexible as possible in order to align with the package “ medications”coming. But of course we have to give Member States time to analyze the proposal before we get to work”she said.
Regulation relating to medical devices
The European Commission adopted a proposal in early January to give suppliers an additional four years to recertify medical devices, in order to avoid the risk of shortages. EU Health Commissioner Stella Kyriakides called on the European Parliament and the Council to swiftly adopt this proposal.
Mrs Johansson assured that it was a “urgent matter” for the chair to ensure patient safety.
“It is crucial that we avoid shortages of life-saving medical devices”said the Minister.
A meeting of the presidency’s working group devoted to this file was held last week. During it, the proposal received strong support from member states, according to Ms Johansson.
The Commission must present this year a revision of the pharmaceutical legislationas well as files relating to orphan drugs and pediatric drugs.
“We hope to obtain a proposal from the Commission”said Ms. Johansson.
The need for a new framework is underlined by the shortages of medicines observed across the Union.
“We are having issues with the supply chain and experiencing shortages as some drugs have not been developed which may be needed in different regions”, underlined Mrs. Johansson. And to add that these questions must be approached jointly.
The issue of shortages of medicines and pharmaceutical products will be discussed at the informal meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on 4 and 5 May, according to the draft Council day.
The Swedish EU Presidency has underlined the importance of orphan drugs and medicines for pediatric use.
“We need to have strategies and tools to grant access to early detection, care, treatment, lifelong care, and the same devices that are available for other diseases”said Ms. Johansson.
The council will consider creating initiatives to secure the drugs needed to fight antimicrobial resistance (AMR), Alzheimer’s disease and other illnesses, Johansson said. Initiatives include coupons and incentives.
“We can’t just rely on big sales, so it’s very important to work with different models, such as incentives”, added Mr. Forssmed. He also indicated that the presidency hopes this will be reflected in the EU executive’s next proposal.
As was the case for the Czech Presidency, cancer is a priority for Swedes. “We must do more to prevent this terrible disease”said Ms. Johansson.
The presidency will organise, together with the Commission, a conference on cancer in Stockholm on 1 February. This will focus on implementing the European plan to fight cancer and ensuring equal cancer care for all.
In addition, advanced cancer diagnostics and treatments will be discussed at a Presidency Conference on the Future of Life Sciences in June.
The Presidency is currently awaiting the Commission’s recommendations on combating AMR, in the hope of adopting them at the EPSCO Council in June.
“We have tried to find ways to use narrow-spectrum antibiotics, but also to supervise the use of antibiotics in humans and animals and to ensure that there are sufficient human resources available to to do so and to observe the situation at the clinical level and in practice”said Ms. Forssmed.
The Member States Meeting on AMR is scheduled for March 6-7 in Stockholm.
Mental health and loneliness
As the European Commission is due to present its mental health strategy by the end of the Swedish presidency, the latter plans to highlight the issue of loneliness.
“Loneliness can have a negative impact on public health, on mental health, on the well-being of the population, as well as on inclusion in society and social cohesion”explained Mr. Forssmed.
He also indicated that the presidency hoped to be able to benefit from the exchange of experiences with other countries on how to approach the issue and on the measures that help to combat loneliness.
Following the change in China’s Covid-19 policy, EU Member States agreed in early January on a coordinated approach to take precautions. The Swedish ministers said that one of the priorities will be to ensure that a coordinated approach is also followed in the future.
“The Swedish Presidency stands ready to facilitate and promote a coordinated EU approach if necessary, and we are monitoring developments very closely”, said Mr. Forssmed. He further noted that while countries take different measures, “the effect is very limited”.
The EU Global Health Strategy, which was adopted at the end of November, aims to improve global health security and ensure better health for all in a changing world.
“The EU must do more with this strategy, do more for global health”, explained Mr. Forssmed. He also indicated that although the goal is to promote health, the strategy also has geopolitical significance.
[Édité par Anne-Sophie Gayet]
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Swedish EU Presidency outlines health priorities
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